IS-001 Injection in Patients Undergoing Robotic-Assisted Colorectal Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: filricianine.
- Who it may be relevant to
- Registry conditions: Ureter Injury. Basic parameters: 16 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase 3 Multi-Center Efficacy Study of Filricianine Injection in Patients Undergoing Robotic-Assisted Colorectal Surgery Using the da Vinci Surgical System With Firefly® Fluorescence Imaging
Overview
This study evaluates the safety and efficacy of intravenous injection of IS-001 to aid in intraoperative ureter structure delineation
Detailed description
Injury to the ureter, the duct by which urine passes from the kidney into the bladder, is a well-known and serious complication of pelvic and abdominal surgery that frequently goes unrecognized intraoperatively. This study seeks to evaluate the safety and efficacy of intravenous IS-001 injection to improve surgeon ureter visualization during robotic-assisted colorectal surgery with the da Vinci® Surgical System and Firefly® imaging.
Interventions
- Drug filricianine
IV injection of IS-001 filricianine with near infrared (NIR) imaging
Primary outcome measures
- Independent reader assessment of ureter visualization by 1-5 Likert visualization rating scale from 1 not visible, 2 questionably visible, 3 low visibility, 4 visible, 5 clearly visible. [Time frame: 10 minutes after first injection]
Secondary outcome measures (12)
- Independent reader assessment of ureter length delineation by line drawing on recorded frame measured in arbitrary unit length [Time frame: 30 minutes after the first injection]
- Independent reader assessment of ureter visualization by 1-5 Likert visualization rating scale from 1 not visible, 2 questionably visible, 3 low visibility, 4 visible, 5 clearly visible [Time frame: 30 miinutes after second injection]
- Independent reader assessment of ureter length delineation by line drawing on recorded frame measured in arbitrary unit length [Time frame: 30 minutes after second injection]
- Ureter visualization based on intraoperative surgeon's rating by 1-5 Likert visualization rating scale from 1 not visible, 2 questionably visible, 3 low visibility, 4 visible, 5 clearly visible [Time frame: 30 minutes after first IS-001 injection]
- Independent reader assessment of ureter visualization by 1-5 Likert visualization rating scale from 1 not visible, 2 questionably visible, 3 low visibility, 4 visible, 5 clearly visible. [Time frame: 45 minutes after first injection]
- Independent reader assessment of ureter visualization by 1-5 Likert visualization rating scale from 1 not visible, 2 questionably visible, 3 low visibility, 4 visible, 5 clearly visible [Time frame: 45 minutes after second injection]
- Concordance of ureter visualization between independent readers [Time frame: 10 minutes after first injection]
- Concordance of ureter visualization between independent readers [Time frame: 30 minutes after first injection]
- Concordance of ureter visualization between independent readers [Time frame: 45 minutes after first injection]
- Concordance of ureter visualization between independent readers [Time frame: 10 minutes after second injection]
- Concordance of ureter visualization between independent readers [Time frame: 30 minutes after second injection]
- Concordance of ureter visualization between independent readers [Time frame: 45 minutes after second injection]
Eligibility criteria
Inclusion criteria
- Male and female participants between the ages of 16 and 75, inclusive
- Participant is scheduled to undergo robotic-assisted colectomy using the da Vinci X/Xi Surgical System with SFF Fluorescence Imaging Exclusion Criteria
1\. Participant is pregnant or nursing 2. Participant has known current acute or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection 3. Participant has any of the following screening laboratory values: eGFR < 30 mL/min/1.73 m2
- Aspartate aminotransferase (AST) ≥ 2.5 × ULN
- Alanine aminotransferase (ALT) ≥ 2.5 × ULN
- Total Bilirubin > 2mg/dL 4. Participant has any concomitant non-colorectal cancer 5. Participant has any circumstances that, in the judgment of the Investigator, might make them not a suitable candidate for the study 6. Participants have already been enrolled in another investigational drug or device study within the past 6 months 7. Participants with known or suspected hypersensitivity to indocyanine green (ICG) or any components of the formulation used 8. Participant is expected to receive or has received other methods for ureter identification during the surgery (e.g., ureteral stent placement, illuminated catheters, retrograde ICG injections) before the administration of IS-001 9. The duration of the surgery is expected to be less than 90 minutes as determined during preoperative planning.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 9 centers
- Hoag Memorial Hospital Presbyterian — Newport Beach
- Yale New Haven Hospital — New Haven
- Orlando Health — Orlando
- Mountain View Hospital — Las Vegas
- The Ohio State Unversity — Columbus
- Kettering Health — Kettering
- St David's North Austin Medical Center — Austin
- HCA Houston Healthcare Medical Center — Houston
- … and 1 more center
Identifiers
NCT: NCT07346066 · ISI-124804-CR-3